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Pregnant women are excluded from many, if not most, clinical trials. Although there are several potential scientific justifications for this exclusion (such as the often unknown effects of the normal physiological changes of pregnancy on drug metabolism), the primary rationale is to minimize the risk of adverse fetal effects from exposure to study-related interventions. Little formal guidance is available on how to develop pregnancy testing plansfor clinical trials. To address this issue, the Clinical Trials Transformation Initiative (CTTI) conducted a project - which included an online survey, a quantitative model, and a meeting of content experts and stakeholders - to develop recommendations for pregnancy testing in clinical research based on currently available evidence. This protocol describes the project methods.

The main purpose of pregnancy testing as part of a clinical research protocol is to minimize risk to an embryo or fetus from exposure to potentially harmful study interventions. The specific goal of testing may be to prevent exposure completely (by testing prior to any study interventions), or to minimize the duration of exposure during early pregnancy (by periodic testing during the study). This survey provided fiveclinical study scenarios and asked respondents a series of questions about the acceptable risk of an unintended fetal exposure to a drug, the importance of several factors going into clinical study design, and the type of pregnancy testing protocol that you would recommend.